MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number M00553560

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2018

Event Type  Death  

Manufacturer Narrative

Date of event: approximated based on the month and year the first procedures were performed.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Report source: literature source: boxhoorn, l., verdonk, r., besselink, m., boermeester, m., bollen, t., bouwense, s., cappendijk, v., curvers, w., dejong, c., van dijk, s., van dullemen, h., van eijck, c., van geenen, e., hadithi, m., hazen, w., honkoop, p., van hooft, j., jacobs, m., kievits, j., kop, m., kouw, e., kuiken, s., ledeboer, m., nieuwenhuijs, v., perk, l., poley, jw., quispel, r., de ridder, r., van santvoort, h., sperna weiland, c., stommel, m., timmerhuis, h., witteman, b., umans, d., venneman, n., vleggaar, f., van wanrooij, r., bruno, m., fockens, p., voermans, r.The dutch pancreatitis study group.Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis.Boxhoorn l, et al.Gut 2023: 72:66-72.Doi: 10.1136/gutjnl-2021-325632.Impact code f02 captures the reportable event of death.

Event Description

Boston scientific became aware of events through the article "comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis" by dr.Rogier p.Voermans, et al.The study compared clinical outcomes after endoscopic transluminal drainage with lumen-apposing metal stents (lams) and double pigtail plastic stents in patients with infected necrotising pancreatitis.According to the literature, 53 patients were to be included in the study performed between june 01, 2018 and march 04, 2020; however, 1 of the 53 patients did not underwent endoscopic transluminal drainage with lams because the necrotic collection could not be visualized by endoscopic ultrasound (eus).Twenty- five patients were implanted with a 15mm x10mm axios stent and electrocautery- enhanced delivery system while 27 patients were implanted with 20mm x10mm axios stent and electrocautery- enhanced delivery system.Study showed 11% mortality rate in lams group while 18% in the plastic stents-group.A total of six patients died post axios stent placement while 9 patients died post plastic stent placement.It is unknown whether the axios stent contributed or caused the patient's death.Note: no further information has been obtained despite good faith efforts.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16363391
• MDR Text Key: 309404102
• Report Number: 3005099803-2023-00666
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death